The proposed rule, if finalized, would amend the FDA informed consent regulations to require that the informed consent documents and processes for applicable drug, biologic, and device clinical investigations include a statement that clinical trial information for such clinical investigations has been or will be submitted to the National Institutes of Health/National Library of Medicine (NIH/NLM) for inclusion in the clinical trial registry databank known as www.ClinicalTrials.gov.

The proposed rule implements Section 801(b)(3)(A) of the Food and Drug Administration Amendments Act of 2007 (FDAAA). This section of FDAAA requires that FDA update its informed consent regulations to require that informed consent documents and processes the clinical investigations in question include a statement that clinical trial information has been or will be submitted to the clinical trial registry databank.

Public comments on the proposed rule must be submitted by March 1, 2010. To learn about submitting comments on the proposed rule, please access http://www.regulations.gov . The document on Informed Consent Elements is Docket No. FDA-2009-N-0592 and/or RIN number 0910-AG32.

Inquiries

Specific questions about this Notice should be directed to:

Office of Extramural Programs
Office of Extramural Research
National Institutes of Health
Email: OEPMailbox@mail.nih.gov